by | 1.0 | OBJECTIVE |
| To lay down a procedure for cleaning and operation of IN-Line Homogenizer. | |
| 2.0 | SCOPE |
| This SOP is applicable for cleaning and operation of IN- Line Homogenizer in medicament mixing area. | |
| 3.0 | RESPONSIBILITY |
| Operator / Production Executive | |
| 4.0 | ACCOUNTABILITY |
| Production-Head | |
| 5.0 | PROCEDURE |
| 5.1 | Cleaning: |
| 5.1.1 | Switch ‘OFF’ and remove the main electric supply of the Homogenizer. |
| 5.1.2 5.1.3 | Dismantle the stirrer rod and propeller from the assembly and transfer to washing area for cleaning. Propeller and stirrer rod: Flush the propeller and stirrer rod with hot water for about 1 minute followed by scrubbing with nylon scrubber using 2% teepol solution /liquid soap for about 5 minutes. Again flush with purified water for about 1 minutes followed by scrubbing with purified water only for about |
| 5.1.4 | 2 minutes. Flush with purified water for about 1 minute and finally rinse with purified water for about 1 minute. Wipe the outer body with lint free duster soaked in purified water and then finally dry with lint free |
| Duster and Intimate to QA for wash water sampling and send wash water to QC department for analysis | |
| 5.1.5 | Assemble the stirrer rod and propeller to motor assembly after getting line clearance for cleanliness from IPQA Executive |
| 5.1.6 | Record entries of cleaning in Equipment log book. |
| 5.2 5.2.1 | Operation: Before operation ensure concerned person must be in proper over gowning and area should be neat and clean. |
| 5.2.2 | Connect the main electric supply. |
| 5.2.3 | Switch ‘ON’ the electric supply. |
| 5.2.4 5.2.5 | Set the propeller of the stirrer in inclined position in the tank. Area should be in temperature and RH limit ( 25±2ºC and 50±5%) |
| 5.2.6 | Switch ‘ON’ the Homogenizer |
| 5.2.7 | Continue the mixing process as mentioned in the BPCR. |
| 5.2.8 | After the completion of mixing, switch ‘OFF’ the Homogenizer. |
| 5.2.9 | Switch ‘OFF’ the electric supply. |
| 5.2.9 5.2.10 | Affix ‘TO BE CLEANE’ label. Record entries of operation in Equipment log book |
6.0 TRAINING
Trainer : Head Production Department
Trainees : Staff and machine operator of production and QA chemist.
7.0 DISTRIBUTION
Master Copy : QA Department
Controlled Copy : Production Department
Display Copy : Production Department
8.0 ATTACHMENTS
Nil
- REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
